Airway implant

ABSTRACT

Methods and apparatuses are disclosed for treating a condition of a patient&#39;s airway. The condition is attributed at least in part to a spacing of tissue from opposing surfaces in the airway. In various embodiments, the base of the tongue including geometry and position of the tongue is altered.

I. CROSS-REFERENCE TO RELATED APPLICATION

The present application is a continuation application of U.S. patentapplication Ser. No. 10/877,003 filed Jun. 24, 2004 now U.S. Pat. No.7,213,599 which is a continuation-in-part of U.S. patent applicationSer. No. 10/698,819 filed Oct. 31, 2003 now U.S. Pat. No. 7,237,554.

II. BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention pertains to a method and apparatus for treating acondition of an upper airway of a patient. More particularly, thisinvention is directed to such a method and apparatus including animplant to improve patency of the airway.

2. Description of the Prior Art

Upper airway conditions such as obstructive sleep apnea (“OSA”) andsnoring have received a great deal of attention. These conditions haverecognized sociological and health implications for both the patient andthe patient's bed partner.

Numerous attempts have been made towards treating OSA and snoring. Theseinclude placing implants in either the tissue of the soft palate or thepharyngeal airway as disclosed in commonly assigned U.S. Pat. No.6,250,307 to Conrad et al. dated Jun. 26, 2003, U.S. Pat. No. 6,523,542to Metzger et al. dated Feb. 25, 2003 and U.S. Pat. No. 6,431,174 toKnudson et al. dated Aug. 13, 2002. Further, U.S. Pat. No. 6,601,584 toKnudson et al. dated Aug. 5, 2003 teaches a contracting implant forplacement in the soft palate of the patient.

In the '584 patent, an embodiment of the contracting implant includestwo tissue attachment ends (for example ends 102b in FIGS. 46 and 47)which are maintained in a space-apart, stretched relation by abio-resorbable member 102c which surrounds an internal spring orresilient member 102a. After implantation, tissue grows into theattachment ends 102b. The bioresorbable member 102c is selected toresorb after the tissue in-growth permitting the resilient member 102ato contract drawing ends 102b together as illustrated in FIG. 47 of the'584 patent (incorporated herein by reference). Tissue contraction isbelieved to be desirable in that the tissue contraction results in adebulking of the tissue and movement of tissue away from opposing tissuesurfaces in the pharyngeal upper airway.

Another prior art technique for treating OSA or snoring is disclosed inU.S. Pat. No. 5,988,171 to Sohn et al. dated Nov. 23, 1999. In the '171patent, a cord (e.g., a suture material) (element 32 in FIG. 6 of the'171 patent) is placed surrounding a base of the tongue and secured tothe jaw by reason at an attachment member (element 20 in FIG. 6 of the'171 patent). In the method of the '171 patent, the member 32 can beshortened to draw the base of the tongue toward the jaw and thereby movethe tissue of the base of the tongue away from the opposing tissue ofthe pharyngeal airway. However, this procedure is often uncomfortable.This procedure, referred to as tongue suspension, is also described inMiller et al., “Role of the tongue base suspension suture with TheRepose System bone screw in the multilevel surgical management ofobstructive sleep apnea”, Otolaryngol. Head Neck Surg., Vol. 126, pp.392-398 (2002).

Two tongue-based surgeries are compared in Thomas et al., “PreliminaryFinding from a Prospective, Randomized Trial of Two Tongue-BasedSurgeries for Sleep Disordered Breathing”, Otolaryngology-Head and NeckSurg., Vol. 129, No. 5, pp. 539-546 (2003). This article compares tonguesuspension (as described above) to tongue advancement (mandibularosteotomy).

Another technique for debulking tissue includes applying radio frequencyablation to either the tongue base or of the soft palate to debulk thetissue of the tongue or palate, respectively. This technique isillustrated in U.S. Pat. No. 5,843,021 to Edwards et al. dated Dec. 1,1998. RF tongue base reduction procedures are described in Powell etal., “Radiofrequency tongue base reduction in sleep-disorderedbreathing: A pilot study”, Otolaryngol. Head Neck Surg., Vol. 120, pp.656-664 (1999) and Powell et al., “Radiofrequency Volumetric Reductionof the Tongue—A Porcine Pilot Study for the Treatment of ObstructiveSleep Apnea Syndrome”, Chest, Vol. 111, pp. 1348-1355 (1997).

A surgical hyoid expansion to treat OSA is disclosed in U.S. Pat. No.6,161,541 to Woodson dated Dec. 19, 2000. Other tongue treatments forOSA include stimulation of the hypoglossal nerve. This procedure isdescribed in Eisle et al., “Direct Hypoglossal Nerve Stimulation inObstructive Sleep Apnea”, Arch. Otolaryngol. Head Neck Surg., Vol. 123,pp. 57-61 (1997).

III. SUMMARY OF THE INVENTION

According to a preferred embodiment to the present invention a methodand apparatus are disclosed for treating a condition of a patient'sairway. The condition is attributed at least in part to a spacing oftissue from opposing surfaces in the airway. In one embodiment, themethod and apparatus include placing a tissue tensioner within thetissue (e.g., within the tongue. Other embodiments show placement ofstiffening elements in the tongue near a base of the tongue. Thestiffening elements may be tissue-crimping members. The elements arealso described as fibrosis-inducing members near the tongue base.Further embodiments include method and apparatus to advance a hyoid boneor epiglottis cartilage of the patient.

IV. BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side elevation, schematic view of a patient illustratingstructure defining an upper airway of the patient and showing an implantaccording to an embodiment of the present invention positioned withinthe soft palate and secured to the bony structure of a hard palate andshowing a similar implant in the tongue and secured to the bonystructure of the jaw;

FIG. 2 is the view of FIG. 1 following contracting of the implants inthe palate and tongue;

FIG. 3 is a view similar to that of FIG. 1 and showing an alternativeembodiment of the present invention with implants of the alternativeembodiment implanted in both the soft palate and tongue;

FIG. 4 is the view of FIG. 3 showing the implants in a contracted state;

FIG. 5 is a view similar to that of FIG. 1 and showing a furtheralternative embodiment of the present invention with an implant of thefurther alternative embodiment implanted in the tongue;

FIG. 6 is the view of FIG. 5 contraction of tissue around the implant;

FIG. 7 is a top plan view of FIG. 5 showing an anterior-posterior axisA-P of the tongue;

FIG. 8 is a view similar to that of FIG. 1 and showing a yet furtheralternative embodiment of the present invention with an implants of theyet further alternative embodiment implanted in the tongue;

FIG. 9 is a view similar to FIG. 7 showing immediate post-implant of astill further embodiment of the present invention;

FIG. 10 is the view of FIG. 9 following tissue in-growth and resorptionof bio-resorbable elements;

FIG. 11 is a view similar to that of FIGS. 1 and 2 showing analternative embodiment;

FIG. 12 is the view of FIG. 11 showing a further alternative embodimentof the invention;

FIG. 13 is a top plan view of the tongue of FIG. 12 and shown withreference to an anterior-posterior axis A-P.

FIG. 14 is the view of FIG. 11 showing a further alternative embodimentof the invention with crimps shown in the tongue in an un-crimped state;

FIG. 15 is a perspective view of the crimp in the state of FIG. 14;

FIG. 16 is the view of FIG. 14 showing the crimps in a crimped state;

FIG. 16A is a top plan view of a tongue showing an anterior-posterioraxis (A-P) and illustrating and alternative orientation of the crimp ofFIGS. 14-16;

FIG. 17 is a perspective view of the crimp in the state of FIG. 16;

FIG. 18 is the view of FIG. 11 showing a further alternative embodimentof the invention with a lever positioned to advance a hyoid bone of apatient;

FIG. 19 is a perspective view of the lever of FIG. 18;

FIG. 20 is the view of FIG. 18 with the lever illustrated as a cable;and

FIG. 21 is the view of FIG. 20 showing a cable secured to an epiglottiscartilage.

V. DESCRIPTION OF THE PREFERRED EMBODIMENT

With reference now to the various drawing figures in which identicalelements are numbered identically throughout, a description of thepreferred embodiment of the present invention will now be provided. Tofacilitate a description and an understanding of the present invention,the afore-mentioned U.S. Pat. Nos. 6,250,307; 6,523,542; 6,431,174;6,601,584; 5,988,171 and 5,843,021 are hereby incorporated herein byreference.

A. Disclosure of Parent Application

The following is the disclosure of U.S. patent application Ser. No.10/698,819 filed Oct. 31, 2003 with additional remarks:

With initial reference to FIG. 1, a soft palate SP is shown in sideelevation view extending from a bony portion of a hard palate HP. Thesoft palate SP extends rearward to a trailing end TE. FIG. 1 alsoillustrates a tongue T with a base TB opposing a pharyngeal wall PW. Ajawbone JB is shown at the lower front of the tongue T.

As a first described embodiment of the present invention, an implant 10is shown in FIG. 1 completely implanted within the tongue T. A similarimplant 10′ is fully implanted in the soft palate SP. As will beapparent, implants 10, 10′ are functionally and structurally similardiffering only in size to facilitate placement in the tongue T and softpalate SP, respectively. As a result, a description of implant 10 willsuffice as a description of implant 10′ (with similar elements similarlynumbered with the addition of an apostrophe to distinguish the implants10, 10′). Further, while both implants 10, 10′ are shown implanted inthe same patient, either could be separately implanted.

The implant 10 includes an elongated member 12 having a tissue in-growthend 14 and a static end 16. The tissue in-growth end 14 may be anytissue growth inducing material (e.g., felt or PET) to induce growth oftissue into the end 14 to secure the end 14 to surrounding tissuefollowing implantation. The elongated member 12 may be suture materialone end secured to the felt 14 and with the static end 16 being a freeend of the suture material 12.

An anchor 18 (shown in the form of a treaded eye-bolt although otherfastening mechanisms could be used) is secured to the jawbone JB. In thecase of implant 10′, the anchor 18′ is secured to the bone of the hardpalate. The end 16 is secured to the anchor 18.

The end 14 is placed in the tongue near the tongue base TB. A surgeonadjusts a tension of the suture 12. This causes the tongue base TB to beurged toward the jawbone JB thereby placing the tissue of the tongue incompression. When a desired tension is attained, the surgeon may tie offthe static end 16 at the bolt 18 retaining the tissue of the tongue Tunder tension. This method and apparatus provides a resistance tomovement of the tongue base TB toward the pharyngeal wall PW. Similarly,with implant 10′, the trailing end TE of the soft palate SP is urgedaway from the back of the throat and the soft palate SP is preventedfrom lengthening.

In the foregoing as well as all other embodiments in this application,one member 14 is shown. It will be appreciated that multiple membercould be placed in the tongue T.

The embodiments of the present application show an anchor placed in thefront center of the jawbone JB. It will be appreciated in this and allother embodiments, the anchor can be placed in other locations (forexample, two anchors can be placed on opposite sides of the jaw bonewith separate elongated members (e.g., elements 12, 10 a, 172, 190 or190′ in the various figures) extending from each anchor.

Placing the implants 10, 10′ under tension as in FIG. 1 provides therapyin that the tongue base TB and soft palate trailing end TE are retainedfrom movement toward the pharyngeal wall PW. In addition, at time ofinitial implantation or thereafter, a surgeon may obtain access toanchors 18, 18′ and further shorten the length of the elongated member12 (i.e., by pulling the member 12 through the bolt 18, 18′) to draw thetongue base or trailing end away from the pharyngeal wall to a newprofile. This is illustrated in FIG. 2 with the contracted profile shownin solid lines TB, TE and contrasted with the original profile shown inphantom lines TB′, TE′.

Referring to FIGS. 3 and 4, an alternative embodiment of the presentinvention is shown as an implant 10 a for the tongue T or implant 10 a′for the soft palate SP. As with the embodiments of FIGS. 1 and 2,implants 10 a, 10 a′ are functionally and structurally similar differingonly in size to facilitate placement in the tongue and soft palate,respectively. As a result, a description of implant 10 a will suffice asa description of implant 10 a′ (with similar elements similarly numberedwith the addition of an apostrophe to distinguish the implants 10 a, 10a′). Further, both implants 10 a, 10 a′ are shown implanted in the samepatient. Either or both implants could be implanted.

Implant 10 a includes a tissue engaging end 14 a and static end 16 a. Asin the embodiment of FIG. 1, the static end 16 a is secured to a hardpalate at the eyelet of an eyebolt 18 a secured to the jawbone JB.Again, as in the embodiment of FIG. 1, the tissue-engaging end 14 a maybe any material which encourages tissue in-growth and attachment totissue. An example of such a material may be PET or a felt material.

The tissue engaging end 14 a and the static end 16 a are connected by aresilient elongated member 12 a which may be in the form of a springmember such as nitinol or other member which may be stretched to createa bias urging ends 14 a, 16 a toward one another. Opposing the bias ofthe spring member 12 a is a bioresorbable material 20 positioned betweenthe tissue-engaging end 14 a and the bolt 18 a.

After placement of the implant 10 a within the tissue of the tongue andwith the end 14 a near the tongue base TB, the bio-resorbable material20 will later resorb into the tissue of the tongue T permitting end 14 ato be urged toward bolt 18 a by the resilience of the spring 12 a. Thisis illustrated in FIG. 4, where the contracted implant 10 a places thetissue of the tongue under tension and urging the tongue base TB awayfrom the pharyngeal wall PW. In FIG. 4, the contracted profile of thetongue base TB (and soft palate trailing end TE) is shown in solid linesand the original profile TB′ (TE′) is shown in phantom lines. Normalfunction of the tongue T is not impaired since the muscles of the tongueT can overcome the bias of the spring member 12 a.

FIGS. 5-7 illustrate a still further embodiment for reducing the tonguebase TB. While term “reducing” is used, it will be appreciated in thisand other embodiments that the tongue need not be reduced in volume butcan be reshaped are simply displaced by the disclosed inventions toachieve the desired effect. In this embodiment, a sheet 30 of tissuein-growth material (e.g., a sheet of felt with numerous interstitialspace) is place in the tongue near the base TB. The sheet 30 is placedbeneath the tongue surface and parallel to the base TB substantiallycovering the area of the tongue base TB. Scarring from the materialcontracts over time resulting in a reduction in the tongue base asillustrated in FIG. 6. To heighten the amount of tongue base reduction,the sheet 30 may be impregnated with a tissue reducing or stiffeningagent (e.g., a sclerosing agent).

FIGS. 9 and 10 illustrate a further variant of FIGS. 5-7. The implant 50includes three tissue in-growth pads 61, 62, 63. A nitinol bar 64connects the pads 61-63 in-line with pad 63 centrally positioned. Thebar 64 is pre-stressed to have a central bend shown in FIG. 10.Bio-resorbable sleeves 65, 66 hold the bar 64 in a straight line againstthe bias of bar 64 as in FIG. 9. The implant 50 is implanted as shown inFIG. 9 with the straight bar 64 parallel to the tongue base TB. Afterimplantation, tissue grows into pads 61-63. After the time period ofin-growth, the sleeves resorb as in FIG. 10. With the sleeves resorbed,the bar 64 bends to its pre-stressed shape. The tongue base moves withthe pad 63 to reposition the tongue base (illustrated in FIG. 10 as theshift from TB′ to TB).

FIG. 8 illustrates a still further embodiment of the invention forreducing the tongue base. Certain muscles of the tongue (particularly,the genioglossus muscles) radiate from the jawbone JB to the tonguesurface as illustrated by lines A in FIG. 8. Contracting implants 40identical to those in FIGS. 46 and 47 of U.S. Pat. No. 6,601,584 areplaced with a contracting axis (the axis between tissue in-growth ends14 a′-identical to ends 102b in FIGS. 46, 47 of the '584 patent) areplaced in the tongue in-line with the muscle radiating lines A.Alternatively, the contracting implant 40 may be of the constructionshown in FIGS. 48 and 49 of the '584 patent. As the implants contractover time, they urge the tongue from collapsing toward the pharyngealwall. In lieu of contracting implants, the elongated implants can bestatic implants such as implants shown in FIG. 11 of U.S. Pat. No.6,250,307 and labeled 20.

B. Additional Disclosure of Present Application

FIG. 11 is a view similar to that of FIGS. 1 and 2 showing analternative embodiment. Elements in common with those of FIGS. 1 and 2are numbered identically. The tissue in-growth end 14 is embedded in thetongue T near the tongue base TB. In stead of an anchor 18 in the jawbone JB as described with reference to FIG. 1, the embodiment of FIG. 11employs and additional tissue in-growth material 118 embedded in thetongue T near the jaw bone JB. An elongated member 12 (e.g., suturematerial) acts as a tension member and connects the base tissuein-growth member 14 to the jawbone tissue in-growth member 118. As inthe embodiment of FIG. 1, the surgeon can adjust the tension on suture12. Alternatively, the suture 12 can be replaced with the elements 12 aand 20 of FIG. 3.

The tissue in-growth material 118 acts as an embedded anchor andeliminates the need for placement of an anchor 18 in the jawbone JB asdescribed in previous embodiments.

FIGS. 12 and 13 show placement of implants 120 in the tongue T near thebase TB. Three implants 120 are shown in parallel alignment near thebase TB and extending generally parallel to the wall of the tongue baseTB. The implants may be polyester braids such as those described in U.S.Pat. No. 6,513,530 to Brenzel et al. dated Feb. 4, 2003 or may becontracting implants such as those described with reference to FIG. 8.The implants 120 tend to stiffen the base of the tongue and resistfloppy action or lack of tone in the tissue of the tongue T near thebase TB. The implants 120 are spaced apart for fibrosis to interconnectbetween the implants 120. In FIG. 12, an alternative placement of theimplant 120 is shown and illustrated in phantom lines as implant 120′.Implant 120′ is positioned near the tongue base TB with one end near thehyoid bone HB and extending upwardly therefrom.

FIGS. 14-17 illustrate the use of imbedded crimps (or staples) tostiffen and potentially reshape the tongue base TB. As illustrated inFIGS. 14 and 15 the crimps 150 are slightly curved members with areplaced in the tongue T with concave surfaces opposing the tongue baseTB. The crimps 150 are crimped by in situ to a crimped U-shape. Thecrimping acting squeezes tissue of the tongue to stiffen the tongue.Crimping can also reshape the tongue base TB as illustrated in FIG. 16(phantom lines illustrating the pre-crimped shape of the tongue baseTB). The crimps 150 may be any biocompatible material which plasticallydeforms to a crimped state. FIG. 16A shows an alternative orientation ofthe crimp or staples 150. The crimp 150 is rotated 180 degrees from theorientation of FIG. 16 with the crimp 150 at the center of the tonguebased TB to result in a crimped in center of the tongue from theoriginal tongue base TB profile shown in phantom lines in FIG. 16A.

FIGS. 18 and 19 illustrate an embodiment to advance the hyoid bone (HB).In FIGS. 18 and 19 and lever 160 is provided with a first end 162adapted to be placed against an anterior surface of thyroid cartilageTC. The end 162 is secured to the thyroid cartilage TC by any suitablemeans (e.g., sutures 164 or staples or bio-adhesives).

The lever 160 is bent to present an abutting surface 166 which abuts aposterior surface of the hyoid bone HB. The bend of the lever causes itto pass through the thyrohyoid membrane TM and the hyoepiglotticligament HL.

A second end 168 of the lever 160 extends above the hyoid bone HB andprojects into the interior of the tongue T. The second end 168 issecured to an anchor bolt 170 in the jawbone JB by a suture or cable 172which is placed under tension by a surgeon. The lever 160 urges thehyoid bone forward (i.e., toward the jaw bone JB) with the advantages ofthe mandibular advancement or mandibular osteotomy procedures.

The lever 160 can be any suitable biocompatible material which hassufficient rigidity to act as a lever of the hyoid bone HB using thethyroid cartilage TC as a fulcrum.

FIG. 20 illustrates a similar embodiment with a cable 190 having a firstend 192 secured to the thyroid cartilage TC by sutures 194. The cable190 is passed around the posterior side of the hyoid bone HB (andpreferably secured thereto by sutures). A second end of the cable 190 issecured to the anchor 170 in the jawbone JB.

FIG. 21 illustrates an alternative embodiment where a cable 190′ has afirst end 192′ secured to the hyoepiglottic ligament HL by sutures. Thecable 190′ passes into and is affixed to the hyoepiglottic ligament HL.The cable 190′ may pass through (as shown) or over the hyoid bone HB.The cable 190′ further passes through the geniohyoid muscle GM andterminates at a second end 194′ at the jawbone JB where it is secured toan anchor 170.

In each of the embodiments shown in FIGS. 18, 20 and 21, in lieu of ajawbone anchor 170, a tissue embedded anchor (such as anchor 118 in FIG.11) could be used.

The foregoing describes numerous embodiments of an invention for animplant for the tongue and soft palate to restrict tissue movementtoward the pharyngeal wall. Having described the invention, alternativesand embodiments may occur to one of skill in the art. It is intendedthat such modifications and equivalents shall be included within thescope of the following claims.

1. A method for treating a condition of a patient's airway wherein saidcondition is attributed at least in part to a spacing of a base of atongue from opposing surfaces of a pharyngeal wall of said airway; saidmethod comprising: selecting at least one implant of fibrosis-inducingmaterial having a longitudinal dimension from a proximal and to a distalend and a transverse dimension narrower than said longitudinaldimension; placing said implant within said tongue with saidlongitudinal dimension extend from the proximal end near a jaw bone ofsaid patient to the distal end near the base of the tongue.
 2. A methodaccording to claim 1 wherein said selecting includes selecting aplurality of implants having structure similar to said at least oneimplant; said placing including placing each of said plurality in saidtongue with proximal ends near a jaw bone of said patient and saidlongitudinal dimensions extending radially outwardly for said distalends near the base of the tongue.
 3. A method according to claim 1wherein said longitudinal dimension is aligned with an axis of agenioglossus muscle of the tongue.
 4. A method according to claim 1wherein said implant is adapted to contract over time.
 5. A methodaccording to claim 1 wherein said condition is snoring.
 6. A methodaccording to claim 5 wherein said condition is sleep apnea.
 7. A methodaccording to claim 2 wherein said implants are spaced apart for fibrosisto interconnect between said members.
 8. A method according to claim 1wherein said implant is placed extending along an anterior-posterioraxis of the tongue.